Freeze-drying/lyophilization of pharmaceutical and biological products
Author(s)
Bibliographic Information
Freeze-drying/lyophilization of pharmaceutical and biological products
(Drugs and the pharmaceutical sciences, v. 137)
M. Dekker, c2004
2nd ed., rev. and expanded
Available at 4 libraries
  Aomori
  Iwate
  Miyagi
  Akita
  Yamagata
  Fukushima
  Ibaraki
  Tochigi
  Gunma
  Saitama
  Chiba
  Tokyo
  Kanagawa
  Niigata
  Toyama
  Ishikawa
  Fukui
  Yamanashi
  Nagano
  Gifu
  Shizuoka
  Aichi
  Mie
  Shiga
  Kyoto
  Osaka
  Hyogo
  Nara
  Wakayama
  Tottori
  Shimane
  Okayama
  Hiroshima
  Yamaguchi
  Tokushima
  Kagawa
  Ehime
  Kochi
  Fukuoka
  Saga
  Nagasaki
  Kumamoto
  Oita
  Miyazaki
  Kagoshima
  Okinawa
  Korea
  China
  Thailand
  United Kingdom
  Germany
  Switzerland
  France
  Belgium
  Netherlands
  Sweden
  Norway
  United States of America
Note
Previous ed.: 1999
Includes bibliographical references and index
Description and Table of Contents
Description
Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD (R) packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.
Table of Contents
Glimpses into the Realm of Freeze-Drying - Fundamental Issues. Structural and Dynamic Properties of Bulk and Confined Water. Mechanisms of Protein Stabilization During Freeze-Drying and Storage: The Relative Importance of Thermodynamic Stabilizationand Glassy State Relaxation Dynamics. Freezing and Annealing Phenomenon in Lyophilization. Freezing- and Drying-Induced Perturbations of Protein Structure andMechanisms of Protein Protection by Stabilizing Additives. Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation, and its Effect on Storage Stability. Formulation Characterization. Practical Aspects of Freeze-Drying ofPharmaceutical and Biological Products Using Non-Aqueous Co-solvent Systems. Closure and Container Considerations in Lyophilization. Advanced Glass-Ware for Freeze-DryingCritical steps in the Preparation of Elastomeric Closures for BiopharmaceuticalFreeze-Dried Products. Development of a new Concept for Bulk Freeze-Drying: LYOGUARD Freeze Dry Packaging. Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture. Freeze-Drying of Biological Standards. IndustrialFreeze-Drying for Pharmaceutical Applications. Development of Process Data In a Pilot Plant Transferable to Production. Technical Procedures for Operation of Cleaning-in-Place and Sterilization-in-Place Process for Production Freeze-Drying Equipment.Freeze-Drying Cycle Parameters Global Validation by Using Integral HFT Systems. Lyophilizer Qualification: Some Practical Advice. Lyophilization Process Validation. A New Development: Irradiation of Pharmaceutical and Biological Products. Some LeadingEdge Prospects in Freeze-Drying
by "Nielsen BookData"